GliomaPhase 1NCT04222309
Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
A Phase 1 study testing Laparoscopically harvested omental free flap in people with Glioma and Glioma, Malignant, run by Northwell Health at 1 site in United States.
Trial summary
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioma, Malignant, Glioblastoma
- What is being tested?
- Laparoscopically harvested omental free flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or female 18 years of age or older.
- Subject is undergoing planned resection of known or suspected GBM.
- Subject has a Karnofsky Performance Status (KPS) 70% or greater.
- Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
- Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
- Subject must be able to undergo MRI evaluation.
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- Subject meets the following laboratory criteria:
- White blood count ≥ 3,000/µL
- Absolute neutrophil count ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin > 10.0 g/dL (transfusion and/or ESA allowed)
- Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN
- Blood urea nitrogen (BUN) and creatinine < 1.5 x ULN
- Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
- Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document
- Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).
- Omental free flap is technically feasible.
Who cannot join
- Subject, if female, is pregnant or is breast feeding.
- Subject intends to participate in another clinical trial.
- Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
- Subject has an active infection requiring treatment.
- Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
- Subject has a history of other malignancy, unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment
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- Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.
- Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has had prior abdominal surgery.
- Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.
- Subject who are unable to have an MRI scan for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lenox Hill Brain Tumor Center
New York, New York, 10075
About this study
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
Read the detailed description
Laparoscopically harvested omental free flaps are commonly used to fill surgical cavities after resection of head and neck cancers. The investigators hypothesize that a laparoscopically harvested omental free flap in our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental free flap with its long vascular pedicle length, wide rotational arc and available surface area would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested omental free makes it an ideal flap for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the blood vessels of the laparoscopically harvested omental free flap should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). "Milky spots" within the omentum will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM.
The investigators aim to prove that this commonly surgical technique for head and neck cancers is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS).
- Conditions
- Glioma, Glioma, Malignant, Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, GBM
- Being tested
- Laparoscopically harvested omental free flap
- Keywords
- blood brain barrier, omental free flap
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopically harvested omental free flapProcedure or surgery
Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopically harvested omental free flap | Experimental | 1. Standard neurosurgical removal of recurrent GBM,
2. Removal of fat from the abdomen called omentum using a camera (laparoscopically),
3. Lining the brain tumor cavity with the piece of omentum,
4. Joining the blood vessels of the omentum to blood vessels in the scalp or neck to ensure that it maintains good blood flow. Receives: Procedure: Laparoscopically harvested omental free flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria
Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 90 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.
Measured: Study Day 1-180
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection
Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 90 days and 180 days.
Measured: Time Frame: Study Day 1-180
Secondary outcomes (3)
Progression Free Survival (PFS)
The proportion of patients who are alive at 6 months from flap implantation and are progression-free will be estimated using standard methods for proportions, along with the associated exact 95% confidence interval.
Measured: 6 months
Overall Survival (OS)
OS will be calculated as the time from treatment initiation (flap implantation) to the time of death.
Measured: 6 months
Percent of screen fails
The number and percent of screen failures with the reason for screen failures (flap not viable etc.) will be tabulated and summarized.
Measured: Study Day 1 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start6 Jan 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Why it stopped: Per IRB closed and opened a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health
- Investigators
- John Boockvar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222309
- Sponsor's protocol ID
- 19-0801
- Status last verified
- May 2026
- First submitted
- 6 Jan 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
- ClinicalTrials.gov ID
- NCT04222309
- Acronym / sponsor ID
- 19-0801
- Conditions
- Glioma, Glioma, Malignant, Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain, GBM
- Keywords
- blood brain barrier, omental free flap
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Per IRB closed and opened a new study.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center, single arm, open-label, phase I study will assess the safety of a laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
All participants included in the study will undergo standard surgical resection for diagnosed recurrent GBM. Following the resection, the surgical cavity will be lined with a laparoscopically harvested omental free flap. The participant's dura, bone and scalp will be closed as is customary. The participant will be followed for side effects within 72 hours, 7 days, 30 days, 90 days and 180 days. Risk assessment will include seizure, stroke, infection, tumor progression, and death.
Detailed description
Laparoscopically harvested omental free flaps are commonly used to fill surgical cavities after resection of head and neck cancers. The investigators hypothesize that a laparoscopically harvested omental free flap in our patients with resected recurrent GBM may be used as a readily available and accessible means of circumventing the blood brain barrier (BBB) selectively and focally. The laparoscopically harvested omental free flap with its long vascular pedicle length, wide rotational arc and available surface area would easily conform to many resected GBM cavities in our human patients with acceptable risk. The predictable and rich vascular anatomy of a laparoscopically harvested omental free makes it an ideal flap for cases of previously irradiated and/or infected wound beds. This is why it is successfully used in head and neck and skull base tumors. The permeability of the blood vessels of the laparoscopically harvested omental free flap should allow for improved delivery of chemotherapeutics and immune cells (macrophages and T cells) into the vicinity, extracellular space and microenvironment of the resected tumor cavity including the brain adjacent to the tumor (BAT). "Milky spots" within the omentum will also provide direct deposition of immune cells such as dendritic, macrophages and lymphocytes into the milieu of the resected GBM.
The investigators aim to prove that this commonly surgical technique for head and neck cancers is safe in a small human cohort of patients with resected recurrent GBM and may improve progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopically harvested omental free flap | Experimental | Procedure: Laparoscopically harvested omental free flap1. Standard neurosurgical removal of recurrent GBM, 2. Removal of fat from the abdomen called omentum using a camera (laparoscopically), 3. Lining the brain tumor cavity with the piece of omentum, 4. Joining the blood vessels of the omentum to blood vessels in the scalp or neck to ensure that it maintains good blood flow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subject is a male or female 18 years of age or older.
- Subject is undergoing planned resection of known or suspected GBM.
- Subject has a Karnofsky Performance Status (KPS) 70% or greater.
- Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
- Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.
Key exclusion criteria (11 listed)
- Subject, if female, is pregnant or is breast feeding.
- Subject intends to participate in another clinical trial.
- Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.
- Subject has an active infection requiring treatment.
- Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopically harvested omental free flapLaparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients. | Procedure or surgery | Laparoscopically harvested omental free flap |
Primary outcome
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria
Time frame: Study Day 1-180
Increase in tumor size relative to baseline will be measured using RANO and assessed by MRI throughout study at within 72 hours, 7 days, 30 days, 90 days and 180 days. Rapidly progressive disease is defined as 25% growth relative to baseline.
Safety parameter: proportion of patients experiencing increase in seizures, stroke, and infection
Time frame: Time Frame: Study Day 1-180
Increase in seizures (defined as 15% relative to baseline), occurrence of a stroke, or occurrence of a severe infection will be determined throughout study within 72 hours, 7 days, 30 days, 90 days and 180 days.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Percent of screen fails
Time frame: Study Day 1 - 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Boockvar, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laparoscopically harvested omental free flap in people with Glioma and Glioma, Malignant, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety parameter: proportion of patients experiencing rapidly progressive disease as indicated by MRI using RANO Criteria (time frame: Study Day 1-180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.